US-based pharmaceutical company Zosano Pharma has enrolled its first patient in its pivotal clinical trial of ZP-Triptan patch treatment to treat acute migraine.
ZP-Triptan is a patented, zolmitriptan-coated, microneedle patch applied onto the patient’s upper arm to deliver zolmitriptan during a migraine attack.
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The multicentre, randomised, placebo-controlled trial is expected to enrol 360 patients within about 35 centres across the US.
The trial is designed to assess the efficacy of ZP-Triptan patch treatment by comparing three doses of ZP-Triptan to placebo for the treatment of a single migraine attack.
It focuses on two co-primary endpoints that include relief from pain after two hours post dosing, as well as remission of symptoms at two hours post-dosing.
Zosano president and CEO Konstantinos Alataris said: "Commencing the pivotal efficacy trial for ZP-Triptan for migraine is a significant milestone as we transition the programme to its anticipated final stage of development and reiterate that we expect to report pivotal efficacy data in 1Q2017.
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By GlobalData"We believe the fast absorption kinetics of ZP-Triptan demonstrated in our Phase I trial have the potential to translate into rapid pain relief for migraine sufferers.
"If established, a rapid pain relief profile, coupled with ZP-Triptan’s simple injection-free mode of delivery, may provide migraine sufferers with an attractive treatment solution."
Zosano Pharma is planning to conduct a safety study of the product following completion of the pivotal efficacy study.
